EC releases updated MDR / IVDR UDI FAQs

The European Commission released an updated version of their Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) Unique Device Identification (UDI) FAQ document. The original document was released in August of 2019.

The revised FAQ document contains updated information on the MDR Date of Application and the deadline for submission to EUDAMED. The dates were changed earlier this year to allow the industry to focus their resources on fighting COVID-19.

To view the document click here.

HIBCC is designated as an Issuing Entity by both the European Commission and the US FDA for their respective UDI initiatives. To learn more about HIBCC and UDI, visit www.hibcc.eu or contact HIBCC directly at udisupport@hibcc.eu or +1 (602) 381-1091.